BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMOVE WIPES BOX OF 50 01

    MDR report key: 7982340 · Received October 18, 2018

    Report

    Report Number
    8043484-2018-00337
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 20, 2018
    Report Date
    December 26, 2018
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KOX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOW CONCLUDED OUR INVESTIGATION INTO THIS PRODUCT COMPLAINT FOR A REMOVE WIPES WHICH CAUSED BURNING. VISUAL INSPECTION OF THE PRODUCT COULD NOT BE COMPLETED SINCE THE PRODUCT TUBE WAS NOT RETURNED. ALSO WITHOUT A LOT NUMBER, A REVIEW OF THE PACKAGING BATCH RECORD COULD NOT BE COMPLETED. ALL BATCHES ARE TESTED FOR COMPLIANCE WITH PRODUCT SPECIFICATIONS PRIOR TO RELEASE. COMPLAINTS OF A SIMILAR NATURE WILL BE CLOSELY MONITORED FOR ANY ADVERSE TRENDS AND FURTHER ACTION CONSIDERED. SMITH AND NEPHEW ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS AND WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT SUFFERED FROM BURNS DURING USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819498 REMOVE WIPES BOX OF 50 01 SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R